On July 15, 2020 Sema4, a patient-centered health intelligence company, reported that it has secured approval from the New York State Department of Health (NYS DOH) to conduct its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) and PanCancer somatic tests (Press release, Sema4, JUL 15, 2020, View Source [SID1234561886]). Sema4 becomes the first company with a commercial laboratory to be approved by the NYS DOH for WES/WTS for solid and hematologic malignancies utilizing tumor-normal analysis. New York State’s approval comes shortly after Sema4’s launch of Sema4 Signal, a new family of products and services providing data-driven precision oncology solutions, including a market-leading hereditary cancer panel composed of a comprehensive 112 gene panel.

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Until now, Sema4 has been offering WES/WTS outside of New York. New York is the only state in the U.S. requiring an independent regulatory review for laboratory-developed tests, which represents one of the most rigorous levels of validation.

Sema4’s WES/WTS test provides clinically-actionable information across the whole exome about a broad range of genomic variants, gene fusion and alternative splicing, and tumor mutational burden and microsatellite instability for solid and hematologic cancers. Sema4 Signal PanCancer, with a ~2,200 gene panel that is the largest in the market, delivers a targeted approach to DNA and RNA sequencing for solid and hematologic cancers. These tests inform on both somatic and germline findings, supported by genetic counseling and digital tools, and can be combined with the Sema4 Signal Hereditary Cancer test and Informatics tools, including clinical trial recruiting.

"New York State’s approval of our somatic profiling solutions is testament to the outstanding accuracy of the tests and reinforces that we have a market-leading solution for clinical care, research, and clinical trials," said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. "Following our announcement about Sema4 Signal, this development further highlights our commitment to using data science to improve cancer treatment. The data we generate from Sema4 Signal WES/WTS and PanCancer will be critical to delivering actionable insights that providers can use to administer care to their current patients while building better predictive models for future treatments."

Sema4 is now starting to engage with the U.S. Food and Drug Administration (FDA) on securing federal government approval for the tests. As part of its mission to improve the diagnosis, treatment, and prevention of disease, Sema4 is also already collaborating with several clinician researchers and investigators, and pharmaceutical companies on initiatives related to its WES/WTS tests.

On July 15, 2020 LintonPharm Co. Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T-cell engaging bispecific antibodies for cancer immunotherapy, reported the China National Medical Products Administration (NMPA) authorized the company to proceed with a Phase III trial (clinicaltrials.gov: NCT04222114) for catumaxomab in patients with peritoneal carcinomatosis, a form of advanced gastric cancer that has spread to the tissue that lines the abdominal cavity (Press release, Lintonpharm, JUL 15, 2020, View Source [SID1234561885]).

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"Gastric cancer is the sixth most common cancer globally. Approximately 70 percent of patients are located in China and the majority of these patients are diagnosed with late stage disease. Given this high unmet need, we are hopeful that catumaxomab will offer a new treatment option to gastric patients"

The two-stage, multi-center, open-label, randomized, controlled registrational clinical trial will evaluate the safety and efficacy of an intraperitoneal infusion of the bi-specific antibody catumaxomab into the abdominal cavity in patients with peritoneal carcinomatosis. LintonPharm also recently received Clinical Trial Application (CTA) authorization for the same indication from the Taiwan Ministry of Health and Welfare (MOHW) and the Korea Ministry of Food and Drug Safety (MFDS).

"We are excited to re-initiate clinical development of catumaxomab which we believe may have benefit in a broad range of cancers," said Robert Li, co-founder and CEO of LintonPharm. "Our initial development strategy is based on a robust foundation of clinical data that support the therapeutic potential of catumaxomab in advanced gastric cancer."

Catumaxomab was the first T-cell engaging bispecific antibody approved by the European Medicines Agency (EMA) in 2009 for the treatment of malignant ascites, a fluid buildup in the peritoneal cavity that indicates the presence of malignant cells. It was later voluntarily withdrawn from the market for commercial reasons.

"Gastric cancer is the sixth most common cancer globally. Approximately 70 percent of patients are located in China and the majority of these patients are diagnosed with late stage disease. Given this high unmet need, we are hopeful that catumaxomab will offer a new treatment option to gastric patients," said Dr. Horst Lindhofer, co-founder and Chief Scientific Officer of LintonPharm.

About Advanced Gastric Cancer with Peritoneal Carcinomatosis

Gastric cancer is the sixth most common cancer globally with an estimated incidence of 1,033,701 cases and 782,685 deaths in 2018.1 About 70 percent of gastric cancer patients are located in China, with 679,100 new cases and 489,000 deaths2 in 2015. More than 70 percent of Chinese patients are diagnosed with late stage (stage III or IV) gastric cancer. Peritoneal carcinomatosis (PC) is one of the primary causes of death in late stage gastric cancer. Approximately 20 percent of patients are diagnosed with PC before or during surgery, and more than 50 percent of patients are diagnosed with PC after cancer reduction surgery. The prognosis for gastric cancer with PC is extremely poor, with an expected survival of less than one year3. Current therapies for gastric cancer include trastuzumab for Her2 positive patients and systemic chemotherapies (1st line and 2nd line). There are limited options for patients who fail frontline therapies, especially for those who developed PC.

About Catumaxomab

Catumaxomab is a trifunctional bispecific antibody which originated from Lindis Biotech’s Triomab platform. The antibody binds to a transmembrane glycoprotein on the tumor cell–the epithelial cell adhesion molecule (EpCAM)–and CD3 on the T-cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab kills tumor cells by engaging T-cell and accessory cell mediated cytotoxicity and has potential to induce long-term vaccinal effects against tumor cells due to the unique FcγR binding and activation profile.

Catumaxomab was first approved by the EMA in 2009 for the treatment of malignant ascites (MA). MA is manifested as the abnormal accumulation of fluid in the peritoneal cavity, which develops from the proliferation of peritoneal carcinomatosis tumor cells in the cavity. There are various cancers that generate MA, for example ovarian, gastric, pancreatic and colorectal cancers. Patients with MA are usually diagnosed in the advanced stages of disease and their quality of life is greatly impaired. Currently, these patients face an extremely poor prognosis with a median overall survival of one to six months.

On July 15, 2020 SYSPRO, a global provider of industry-built enterprise resource planning (ERP) software, reported that Freenome Holdings, Inc., a biotechnology company dedicated to early cancer detection, has chosen SYSPRO ERP Software to streamline and enhance its business for optimal growth (Press release, Freenome, JUL 15, 2020, View Source [SID1234561883]).

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Freenome has pioneered the most comprehensive multiomics platform for early cancer detection with a routine blood draw, beginning with a colorectal cancer screening test. The company is integrating actionable insights through a machine learning feedback loop with healthcare providers, to leverage real-world data and improve patient care through early detection.

To continue on a path of innovation and growth, Freenome looks to SYSPRO and its specialized technology partner, Operations Resource Group (ORG), to strengthen and streamline its processes through integrations and modular capabilities. Areas of focus include accounting, financial reporting, controls, workflow, compliance, and security.

"Our team has implemented SYSPRO with another company and have found the experience very easy, collaborative, and informative. The urgency at Freenome to have an ERP system in place is similar to our last experience. The SYSPRO and ORG teams have delivered thus far to our expectations," said William Quirk, Freenome Chief Financial Officer.

"I speak on behalf of the entire SYSPRO team when I say that we are proud to be part of Freenome’s journey in fighting cancer," said Scott Hebert, SYSPRO USA Chief Sales Officer. "Freenome is a prime example of how SYSPRO’s manufacturing and distribution customers are changing the world by integrating new technologies and streamlining business practices."

"We are thrilled to partner with a company as forward-thinking and innovative as Freenome," said Julia Maynard, Project Manager, Operations Resource Group. "Any support that we can provide to help further Freenome’s cause to save lives is of upmost importance to us."

On July 15, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a multicenter, prospective study demonstrating that DecisionDx-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (UM) (Press release, Castle Biosciences, JUL 15, 2020, View Source [SID1234561882]).

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The article titled, "Gene expression profiling in uveal melanoma: five-year prospective outcomes and meta-analysis," was published in the peer-reviewed journal Ocular Oncology and Pathology.

DecisionDx-UM is Castle’s 15-gene expression profiling (GEP) test developed to identify patients at low risk (Class 1) or high risk (Class 2) of metastasis, based on the unique biology of their primary tumor, and is the current standard of care for UM patients. It is estimated that nearly 8 in 10 patients diagnosed with UM in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. UM patients face up to a 50% risk of metastasis, despite successful control of the primary tumor.

The multicenter CLEAR Registry Study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate management plans and five-year clinical outcomes for UM patients tested with DecisionDx-UM as part of their clinical care. The median follow-up time for patients who did not develop metastasis was 4.9 years, reflecting the longest follow-up reported to date for any prognostic tool for UM.

"The accurate and reliable identification of a patient’s metastatic risk is critical for clinical planning and decision-making," commented first author, Thomas Aaberg, Jr., M.D., associate clinical professor at Michigan State University Medical School and ocular oncologist with Retina Specialists of Michigan. "As with previously published studies, the results of the CLEAR study demonstrate the high-level of accuracy of DecisionDx-UM for prediction of metastatic risk and further support its use in guiding patient management."

Study Background and Highlights:

Eighty-nine patients with DecisionDx-UM results were prospectively enrolled at four centers. Sample size calculations indicated that 29 patients would be sufficient to demonstrate a statistically significant difference in metastatic rates between Class 1 and Class 2 patients, while 47 patients would be sufficient to detect differences in melanoma-specific mortality.
Physician-recommended management plans were collected, and clinical outcomes tracked every six months.
Five-year DecisionDx-UM Class 1 and DecisionDx-UM Class 2 metastasis-free survival rates were 90% and 41% (p<0.0001), respectively, and melanoma-specific survival rates were 94% and 63% (p=0.0007), respectively.
In multivariate analysis with clinicopathologic features, including age, ciliary body involvement, largest basal diameter and tumor thickness, the DecisionDx-UM Class 2 result was the only statistically significant predictor of metastasis, with a hazard ratio (HR) of 7.53 (p<0.0001).
A meta-analysis with published cohorts found that patients with a Class 2 result had a HR of 8.70 (p<0.0001) for metastasis and 7.21 (p<0.0001) for mortality.
All patients with DecisionDx-UM Class 2 (high-risk) test results were managed with high-intensity surveillance (imaging and/or liver function tests every 3-6 months), while 80% of Class 1 (low-risk) patients were managed with low-intensity surveillance (annual imaging and/or liver function tests, p<0.0001).
The results of this study support that DecisionDx-UM is used to appropriately guide metastatic surveillance in UM patients. High-risk Class 2 patients were managed more intensely, in accordance with an observed metastatic rate of greater than 50%, while low-risk Class 1 patients were managed with low-intensity surveillance, resulting in appropriate utilization of healthcare resources.
About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On July 15, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported entering into an agreement with a fund affiliated with institutional investors providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock (or common stock equivalents), together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.1 million (Tranche 1) (Press release, Idera Pharmaceuticals, JUL 15, 2020, View Source [SID1234561880]). The combined purchase price per share of common stock (or common stock equivalent) and accompanying full warrant was $1.845. The common stock warrants have an exercise price of $2.58 per share and a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of 19.99% of the total number of shares of common stock then issued and outstanding (Beneficial Ownership Limitation).

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Pursuant to the agreement, the investors may, at their option, make a further investment of an additional $5.1 million to purchase shares of common stock equivalents, together with accompanying common stock warrants to purchase additional shares of common stock with 35% warrant coverage (Tranche 2). The combined purchase price per share of common stock (or common stock equivalent) and accompanying 0.35 warrant will be $6.50 per share. The common stock warrants, if issued, will have an exercise price of $9.75 per share, a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of the Beneficial Ownership Limitation.

The investors’ option to invest in Tranche 2 must occur no later than the tenth business day following the announcement of overall response rate data from the Company’s ILLUMINATE-301 trial of its lead product, tilsotolimod, in combination with ipilimumab for the treatment of anti-PD-1 refractory advanced melanoma. To the extent Tranche 2 is closed and inclusive of proceeds from the exercise of warrants issuable in this private placement, the Company may receive up to $20.0 million in gross proceeds.

The Company plans to use the initial proceeds and, if exercised, subsequent proceeds from the financing for the ongoing clinical development of tilsotolimod, its potential NDA filing and commercial launch, and for general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.